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Alzheon Alzheimers Trial Misses Primary Endpoint

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Alzheon says its Phase 3 valiltramiprosate trial in early Alzheimers disease patients did not meet its primary endpoint of slowing...

FDA Clears Dexcom Glucose Monitor

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FDA clears the Dexcom G7 15 Day continuous glucose monitoring system.

FDA Clears Intuitive Stapler for da Vinci Robot

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FDA clears an Intuitive 510(k) for the SP SureForm 45 stapler for use with its da Vinci SP surgical system in thoracic, colorectal...

Support, Suggestions for FDA Regulatory AI Guidance

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Two stakeholders voice support for an FDA draft guidance on using AI in drug and biologic regulatory decision-making and ask for a...

Zeiss Medical Gets Clearance for Intrabeam 700

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FDA clears a Zeiss Medical Technology 510(k) for its Intrabeam 700, a robotic-assisted platform to support intraoperative radiatio...

Generic Policy Shop Cuts will Hurt ANDAs: Post

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Hyman, Phelps & McNamara attorney Kurst Karst says recent staff cuts at FDA that eradicated the Office of Generic Drugs Division o...

Outlook Refiles BLA for Wet AMD Drug

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FDA accepts for review an Outlook Therapeutics BLA resubmission for ONS-5010 (bevacizumab-vikg), an investigational ophthalmic for...

Coordinate HHS Drug Shortage Activities: GAO

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The Government Accountability Office says HHS should have some mechanism in place to coordinate the activities of various HHS agen...

FDA OKs Dropping Tryvio REMS

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FDA approves updated labeling for Idorsias blood pressure drug Tryvio after approving the elimination of a REMS requirement.

Raskin, Others Seek FDA Meeting on Cuts

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Members of Congress from Maryland, led by Rep. Jamie Raskin, ask to meet with FDA commissioner Martin Makary to discuss their conc...